Evidence map›Paper›PMID 33425672›Full record

ArticleJournal of bone oncology2021

Effects of abiraterone acetate plus prednisone on bone turnover markers in chemotherapy-naïve mCRPC patients after ADT failure: A prospective analysis of the italian real-world study ABITUDE.

Daniele Santini, Saverio Cinieri, Donatello Gasparro, Roberto Bordonaro, Pamela Francesca Guglielmini, Vincenzo Emanuele Chiuri, Rolando M D'Angelillo, Giovanni Luca Ceresoli, Daniele Fagnani, Mirko Acquati and 7 more

Open access · goldAbstract read
In one paragraph

Article in Journal of bone oncology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.5field-weighted citation impact, top 29% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 5 citations in OpenAlex.

  1. Review
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors at 15 institutions in 1 country.

Daniele SantiniDepartment of Oncology, Campus Bio-Medico University, Rome, Italy.
Saverio CinieriMedical Oncology Unit, Antonio Perrino Hospital, Brindisi, Italy.
Donatello GasparroMedical Oncology Unit, Department of General & Specialistic Medicine, University Hospital of Parma, Italy.
Roberto BordonaroMD - ARNAS Garibaldi, Catania, Italy.
Pamela Francesca GuglielminiMedical Oncology Department, Ospedale SS Antonio e Biagio e Cesare Arrigo, Alessandria, Italy.
Vincenzo Emanuele ChiuriMedical Oncology Department, Ospedale Vito Fazzi, Lecce, Italy.
Rolando M D'AngelilloDepartment of Biomedicine and Prevention, Tor Vergata University, Rome, Italy.
Giovanni Luca CeresoliDepartment of Oncology, Cliniche Humanitas Gavazzeni, Bergamo, Italy.
Daniele FagnaniMedical Oncology Division - ASST, Vimercate, Italy.
Mirko AcquatiUnit of Medical Oncology, Azienda Ospedaliera San Gerardo, Monza, Italy.
Manlio MencoboniOncology Unit, Villa Scassi Hospital, 16149 Genova, Italy.
Gaetano LanzettaDepartment Oncology and Palliative Care, INI Grottaferrata, Rome, Italy.
Donata SartoriOncology Unit, AULSS 3, Mirano, Italy.
Paolo CarliniDivision of Medical Oncology 1, IRCCS "Regina Elena" National Cancer Institute, Rome, Italy.
Fabiana PanebiancoMedical Affairs Department, Oncology, Janssen-Cilag SpA, Cologno Monzese, Milan, Italy.
Patrizia BeccagliaMedical Affairs Department, Oncology, Janssen-Cilag SpA, Cologno Monzese, Milan, Italy.
Giuseppe ProcopioDepartment of Medical Oncology, Fondazione IRCCS, Istituto Nazionale dei Tumori, Milano, Italy.
Janssen (Italy) · ITAzienda Ospedaliera di Desio e Vimercate · ITAzienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo · ITAzienda Ospedaliera San Gerardo · ITFondazione IRCCS Istituto Nazionale dei Tumori · ITHumanitas Gavazzeni · ITIstituti di Ricovero e Cura a Carattere Scientifico · ITOspedale A. Perrino · ITOspedale di Mirano · ITOspedale Garibaldi · ITOspedale Vito Fazzi · ITUniversità Campus Bio-Medico · ITUniversity of Parma · ITUniversity of Rome Tor Vergata · ITVilla Torri Hospital · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBone remodeling is disrupted in metastatic disease, which affects > 70% of metastatic castration-resistant prostate cancer (mCRPC) patients. As a result, abnormal levels of specific bone turnover biomarkers (BTMs) are released. In this prospective ancillary analysis of the Italian real-world study ABITUDE, four markers were measured during abiraterone acetate plus prednisone (AAP) treatment in chemotherapy-naïve mCRPC men failing androgen-deprivation therapy.

methodsPatients were enrolled if a blood sample was obtained before the first administration of abiraterone (baseline); ad-hoc blood samples were withdrawn during routine tests after 3, 6, and 12 months. A centralized lab measured bone alkaline phosphatase (BALP, osteoblast activity marker), type-I collagen-C-telopeptide (CTX-1, bone resorption marker), parathyroid hormone (PTH) and vitamin D (vitD). At each time point, intra-patient variations vs baseline were compared by the signed-rank test (statistical significance: P-value < 0.05).

resultsOf 481 patients enrolled in ABITUDE, 186 (median age: 76 [range: 53-93] years) met the substudy criteria: 74.7% had bone metastases, 11.8% were on bone-targeted therapies (BTT) and 14.0% on vitD supplementation. BALP decreased significantly at month 6 (P = 0.0010) and 12 (P < 0.0001) and CTX-1 at month 6 (P = 0.0028); PTH increased at month 3 (P < 0.0001); no significant difference in vitD levels was observed. Similar findings were observed in BTT-untreated patients. The reduction in BALP and CTX-1 levels was more pronounced in patients with than without bone metastases; in the latter group, no significant variation in BALP and CTX-1 levels was observed.

conclusionsAAP seems to exert an effect on the microenvironment of metastatic but not of normal bone, which likely contributes to its antitumoral activity.

Indexed as

Abiraterone acetateBone alkaline phosphataseBone targeting therapyBone turnover biomarkersC-terminal telopeptidemCRPC

Identifiers

PMID33425672
PMCPMC7779770
OpenAlexW3107352748

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.